Compounding series shows good, bad of industry

The Ocala Star-Banner deserves credit for devoting the resources and space to the subject of pharmacy compounding. It is a topic very much on the minds of local readers due to the tragic deaths of several residents from the meningitis outbreak relating to the New England Compounding Center (NECC) as well as earlier adverse events involving a local compounding pharmacy.

We are grateful that the paper called our organization and our board members for comment and perspective. We offer the following comments in response to the series and the related editorial.

Consistency is key. States must adopt uniform standards that will ensure patient safety, and chief among those is USP 797, the standard for sterile compounding. USP 797, and USP 795 for nonsterile compounding, keep patients safe and should be recognized as the standard by every state in the union.

Our organization long has fought for greater consistency in state standards. Those standards need to be applied not only to compounding pharmacies but to all other settings in which customized medications are prepared, including hospitals, physician offices and surgical centers.

Regulations only work when enforced. The best regulations will not keep patients safe. They must be enforced through unannounced inspections. Case in point: Massachusetts. The Bay State had some of the best regulations in the land, yet NECC still allegedly committed gross errors that led to patient deaths and illness.

The state, while having clear and firm regulations, did not adequately enforce them because it did not devote the necessary resources to inspections.

H.R.6611 Alert...Patient Access to Drugs in Shortage Act of 2012

Patient Access to Drugs in Shortage Act of 2012—Amends title XVIII (Medicare) of the Social Security Act (SSA), with respect to use of average sales price payment methodology for drugs and biologicals, to prescribe a formula for determining the payment amount, using the volume-weighted wholesale acquisition cost, for a multiple source or a single source sterile injectable drug product with three or fewer active manufacturers, if there is no period of exclusivity in effect or available.Incorporates such payment methodology under the hospital outpatient department prospective payment system for any such drug furnished between July 1, 2013, and January 1, 2020.Amends SSA title XIX (Medicaid) to exempt from the rebate agreement requirement a multiple source drug furnished between July 1, 2013, and January 1, 2020, and for which payment may be made under Medicare part B (Supplementary Medicare Insurance).Amends the Public Health Service Act to exclude such multiple source drugs from the term "covered outpatient drug" subject to specified price limitations under the "340B" drug pricing program.Directs the Secretary to contract with an independent entity to study the effects of this Act on patient access to sterile products.Amends the Patient Protection and Affordable Care Act to exclude certain branded prescription drugs on a specified drug shortage list from the annual fee imposed on branded prescription pharmaceutical manufacturers and importers

Today's Shortages

ASHP/FDA
Adacel/Tubersol
Dihydroergotamine Mesylate Injection
Fludarabine Injection
Heparin Sodium Injection
Prednisone Tablets

Medication crisis

The patient was found by paramedics and rushed to the hospital. He had taken over 80 aspirin tablets of 500 mg each — more than enough to be lethal. The ER staff prepared to administer the standard treatment for aspirin poisoning: sodium bicarbonate. Yes, this is the same stuff seen in movies that anxious characters take to relieve stomach upset and is followed by a burp. Chemically it's a simple, inexpensive medication and has been used for decades. In this case, the bicarbonate is a sterile solution given intravenously. But when the order was sent to the hospital pharmacy, the answer came back that there was no bicarbonate solution available. The only alternative would be to begin emergency dialysis, a far more expensive and risky procedure.

In the Maryland legislature we heard this story from a physician practicing at a university teaching hospital. In answer to an urgent distress call to nearby hospitals, a few vials were located and used to save the patient.

Stories like this are common throughout the nation as a crisis in medication shortage continues to expand. Basic medications are missing: injectable generics like epinephrine (for severe allergic reactions and cardiac resuscitation), Compazine (relief of nausea and vomiting), Novocain (local anesthesia), Ativan (seizure control).

At one hospital, weekend elective surgeries were canceled, and even emergency surgeries were threatened. They didn't have enough anesthetic to put people to sleep safely or the antidotes needed to wake them up.

But the problem goes deeper: patients are suffering and dying because they're not receiving optimal treatment. A year ago, The New England Journal of Medicine documented significantly worse outcomes in children with cancer when one medicine was substituted for another, and a recent survey of cancer doctors published last month reported that 82.7 percent "were unable to provide the preferred chemotherapy agent at least once … during the previous 6 months."

Brenda Frese, coach of the University of Maryland women's basketball team, became aware of the problem when one of her twin sons was in short supply for a medication he needed. She wrote, "from what I understand, the shortage [of life-saving drugs] isn't the result of a lack of natural resources or research dollars, but simply a choice by pharmaceutical companies because their profit margin on the drug isn't high enough. This is wrong on every level."

A pharmacist at Johns Hopkins Hospital testified before a Maryland legislative committee, "This morning I spent 3 hours on a conference call reviewing a list of 97 medications we're actively managing right now that are on shortage. We do not purchase any drugs that we cannot ensure the integrity of, but in some cases unfortunately that has caused us to say to a patient that we cannot provide you with treatment, and that's something we never want to do."

What happens next? The pharmacy staff tries to track down the missing meds, too often from suppliers of questionable reliability. A bargaining process ensues, carried out by fax and email. Costs often rise drastically as demand outstrips supply. For example, the price of doxycycline, an antibiotic used to treat Lyme disease, jumped from about $2.50 to between $80 and $150 for a 60-pill, one month treatment. Magnesium sulfate (used to treat toxemia in pregnancy) went from $9 to $400 for 25 vials.

Our national medication shortage stems from multiple causes. There are problems with manufacturing as companies (often located overseas) cut corners and risk contamination in medicines with small profit margins. A "gray market" has emerged, complete with price gouging and manipulation, hoarding and back-door delivery of medicines, some of which have been improperly stored.

This crisis needs immediate attention on many levels. The Food & Drug Administration's passive approach — limited to generating lists of impending drug shortages — should become proactive by expediting permits for qualified producers and creating an exchange system so medicines are distributed where needed. Hospitals could establish extensive buying consortiums and partner directly with manufacturers to eliminate the dozens of "middle men" engaged in profiteering. State health departments could create medication repositories for sharing, as was done during the flu vaccine shortage a few years ago. Ultimately, we need to bring pharmaceutical manufacturing back to the U.S., employing the latest and safest techniques for drug production.

As a practicing physician, I don't want to be reaching for a life-saving medicine when trying to manage a patient in crisis and finding that there's none to be found.

As a patient and family member, I want our doctors to have the right medicines available when treating my loved ones and me.

And as a legislator, I know that public awareness is essential to creating solutions. Just about all of us, our families, and our friends have had occasion to be treated with medicine or been admitted to a hospital in the past few years. There is cause for concern; we must let our representatives know that action is needed now to solve this mess.

Dan K. Morhaim is a physician and a member of the Maryland House of Delegates, representing District 11 in Baltimore County. His email is dan.morhaim@house.state.md.us.

To respond to this commentary, send an email to talkback@baltimoresun.com. Please include your name and contact information.

Read more: http://www.baltimoresun.com/news/opinion/oped/bs-ed-medication-shortage-20140104,0,4291008.story#ixzz2pZPt9ZCY

Time to Fix Glitch in Pharmacy Law?

After a long delay, the Florida Department of Health wants to fix a gap in the law that made it powerless over out-of-state compounding pharmacies.

When tainted injections from New England Compounding Pharmacy caused a fungal meningitis epidemic in 2012, the state discovered it had licensed hundreds of such facilities to send drugs into Florida. It also found that Florida law gave DOH no authority over those located in other states.

DOH could have asked the legislature to fix the gap in the law during the 2013 session in the spring, but did not, as Health News Florida reported last June (see Who Forgot to Fix Compounding Law?). It was never made clear who dropped the ball.

In any event, DOH now has a proposed bill – approved by the Board of Pharmacy in October – that would plug the gap. It would allow Florida to send or hire inspectors to an out-of-state licensee and bill that pharmacy for the cost.

It also would require the pharmacy to provide a toll-free number that patients in Florida could call and maintain clear records of who got which drugs so that if there were a problem, those at risk could be contacted.

Sixty-four people, including seven in Florida, were killed by the outbreak caused by contamination of the steroid injectable liquids shipped from New England Compounding Pharmacy,  according to the Centers for Disease Control and Prevention.

The pharmacy that made the tainted drugs was shut down soon after the outbreak was discovered in September 2012, and was later declared bankrupt. Other Florida-licensed compounding pharmacies based in and out-of-state also have triggered outbreaks or been found to be operating in dangerous conditions by DOH or the U.S. Food and Drug Administration.

Compounding pharmacies are allowed to tailor-make a drug for an individual patient who can't use the official mass-produced version, and if they have a doctor's prescription. These pharmacies are not supposed to mass-produce other companies' patented drugs or sell them in bulk.

But in recent years, many compounders have become de facto manufacturers without an FDA license, as that agency discovered after the NECC outbreak.

Current Florida law leaves it up to other states to monitor the compounders based inside their borders. But outbreaks caused by bad drugs produced in Florida and a number of other states – as listed recently by the Ocala Star-Banner’s Fred Hiers -- indicate that system hasn’t worked.

Recognizing that, in November 2013 Congress passed and President Obama signed into law the Drug Quality and Security Act, which attempts to clarify federal law so that the FDA would have more authority over bulk compounders under a new classification:  “outsourcing facilities.”

However, the federal law appears to leave state health officials in charge of monitoring traditional compounding pharmacies; it’s unclear whether the language proposed by the DOH will need tweaking.  DOH “is in the process of analyzing the impact of the federal legislation,” agency Press Secretary Sheri Hutchinson wrote in an e-mail reply to a question.

Another discovery: Most states, including Florida, had no idea how many of their licensed pharmacies were making their own compounded drugs and – more worrisome – how many of those drugs were in the high-risk “sterile” category because they were to be infused or injected into the blood stream (see Florida Law, Health Agency Lax on Compounding Pharmacies).

A late-2012 DOH survey of licensed pharmacies found that about 4,500 engaged in compounding to some extent and about 950 of those were making high-risk products. The numbers were regarded as staggering, given that there were only a handful of state pharmacy inspectors trained to gauge the safety of such facilities.

As of last month, according to DOH, there were 687 pharmacies with Florida licenses engaged in sterile compounding, of which 418 had been inspected since July 1. DOH found 94 with safety violations, half of them serious.

In the past year the Florida Board of Pharmacy has adopted several rule changes after study and hearings by its Compounding Committee. The Board:

--Now requires sterile compounders to apply for a special permit that requires an inspection before license issue or renewal.

--Requires sterile compounders based in other states to submit copies of their last two inspections in their home state.

--Is scheduled to act in February on a proposal that would raise the safety standards that sterile compounders must meet (to USP 797, set by the U.S. Pharmacopeial Convention).

http://health.wusf.usf.edu/post/time-fix-glitch-pharmacy-law

Alexander plans to keep tabs on FDA work with compounding pharmacies

U.S. Sen. Lamar Alexander wants to monitor how well the U.S. Food and Drug Administration is using a new law passed by Congress to prevent another fungal meningitis outbreak.

He said today that he will push for an oversight hearing on the agency’s regulation of compounding pharmacies. FDA Commissioner Margaret Hamburg has said the law does not give her agency all the powers it would have liked, but that it was a step forward in defining regulatory authority. Members of Congress criticized her agency for failing to do its job when a contaminated steroid made by Massachusetts-based New England Compounding Center caused an outbreak that sicked 751 people with 64 deaths.

Tennessee has been one of the hardest hit states.

“We worked for a year to create legislation that would help prevent another meningitis outbreak like the one that killed 16 Tennesseans and made so many others sick,” Alexander said. “Tennesseans deserve to know that the FDA and other regulators are properly implementing this new law, which makes clear who is on the flagpole to prevent another nightmare like the deadly meningitis outbreak of 2012.”

One criticism of the law is that it allows compounders to voluntarily register with the FDA as “outsourcing facilities” and become subject to the same rules and regulations as drug manufacturers. Compounders who do not register will continue to be regulated by state boards of pharmacy. The law also sets up a framework that will eventually allow for better tracking of drugs.

The Drug Quality and Security Act was signed into law by President Obama on Nov. 27. Alexander worked with members of the U.S. House of Representatives to come up with compromise legislation.

http://www.tennessean.com/article/20140103/NEWS07/301030101/Alexander-plans-keep-tabs-FDA-work-compounding-pharmacies?nclick_check=1

Drug shortages force docs to replace cancer drugs with more expensive meds

Big Pharma pulls a billion dollar bait-and-switch

Has this ever happened to you? You pick up the Sunday paper, and spot an unbelievable deal.

It seems too good to be true — and, of course, it is. You hustle down to the store, only to have the salesman claim that they “just sold” the last one. But he has plenty of more expensive models he’d just LOVE to show you.

We expect those kinds of bait-and-switch shenanigans by sleazy salesman — but you shouldn’t have to deal with them when you’re fighting cancer.

That’s why I’m galled to the core by a shocking new report published in the New England Journal of Medicine. It turns out Big Pharma is forcing cancer docs to replace your drugs with more expensive (and potentially much less effective) versions.

It’s a story almost too sickening to believe. Researchers surveyed 200 cancer docs. Four out of five said that at least once during the past six months they were unable to prescribe the cancer med of choice due to a “drug shortage.”

And guess which drugs ALWAYS seem to be suffering from a shortage? Cheaper generics.

Oncologists had to regularly make major changes to treatment programs. And way too often that change is substituting unproven drugs or much less successful ones.

And more often than not, these docs were switching to drugs that were dramatically more expensive than the meds they wanted to use. Sixty percent of docs reported having to use a more expensive, brand name drug when they couldn’t get their hands on a generic.

Awfully convenient for Big Pharma, wouldn’t you say? In fact, in some cases, doctors had to opt for a designer drug that was a whopping 140 times more costly.

Let’s face it — the only part of you that Big Pharma cares about is leather, foldable and sitting in your back pocket. And the worst part is that while drug companies are raking in BILLIONS in profits off of these so-called drug shortages, cancer doctors say you’re probably getting worse care.

It’s time to have a frank talk with your doctor — ask him about the drugs he’s using, and find out if they’re even his first choice. You may find that Big Pharma is laughing all the way to the bank, and the joke is on you.

- See more at: http://wrightnewsletter.com/2014/01/01/drug-shortages-force-docs/#sthash.GIcPPUV0.dpuf